Summary:
Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory did not evaluate molecular microbiology proficiency test results and investigate unsuccessful proficiency test results. Findings: 1. API is the proficiency test (PT) provider for the molecular microbiology testing performed by the laboratory. Three times each year the PT provider sends samples to the laboratory to test. The PT provider then evaluates the laboratorys responses for accuracy. The laboratory receives a detailed report (evaluation report) that shows each reported test result and if the laboratory's response passed or failed in meeting the expected test result. 2. The laboratory did not perform a root cause analysis when the analyte for the organism Escherichia coli was given an unsatisfactory score of 60 % for the second event of 2024 (the laboratory failed to detect the organism for two of five samples). 3. There was no investigation into the unsatisfactory performance that would have also included a determination of risk for patient test results going back to the failed PT event. 4. This was confirmed during interview with testing staff on August 27, 2025 at 2:00 pm. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on record review and interview the laboratory did not evaluate proficiency test results that the proficiency test (PT) provider did not evaluate due to lack of peer group or agreement. Findings: 1. API is the proficiency test (PT) provider for the molecular microbiology testing performed by the laboratory. Three times each year the PT provider sends samples to the laboratory to test and then evaluates the laboratorys response for accuracy. The laboratory receives a detailed report (evaluation report), from the PT provider, that shows each reported test result and if the laboratory's response passed or failed in meeting the expected test result. 2. The laboratory did not evaluate PT results for the second and third events of 2024 that the PT provider did not evaluate due to lack of peer group. Examples of the tests not evaluated included the presence or absence of genes for antimicrobial resistance. 3. This was confirmed during interview with testing staff on August 27, 2025 at 2:00 pm. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory did not have the proficiency test providers evaluation for the molecular microbiology testing performed. Findings: 1. API is the proficiency test (PT) provider for the molecular microbiology testing performed by the laboratory. Three times each year the PT provider sends samples to the laboratory to test and the PT provider evaluates the laboratorys response for accuracy. The laboratory receives a detailed report (evaluation report) that shows each reported test result and if the laboratory's response passed or failed in meeting the expected test result. 2. The laboratory did not have this evaluation report for the first and second event of 2025. 3. This was confirmed during interview with testing staff on August 27, 2025 at 2:00 pm. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory director did not ensure that quality control programs were maintained for the microbiology molecular testing performed by the laboratory. Findings: 1. The laboratory records for performing quality control checks were incomplete and did not identify the staff member(s) responsible for conducting this control check, did not identify the date performed and did not provide the results of these checks. 2. For example, the laboratory performs a wipe test to ensure that the laboratory surfaces are clean and there is no DNA contamination to cause false readings for patient test results. 3. There are two reports to document the wipe test activity, the first report is called the Wipe Test 2024 report -- 2 of 3 -- (first report), this report is to document the performance of the wipe test and the second report is called the Wipe Test Monthly Maintenance Completed Log Form Review (second report), this report is to document the review of the entries recorded on the first report to ensure that they were complete. 4. The first report (for the year 2024) showed that the Wipe test was performed only on the months of February 12, 2024, May 31, 2024, July 29, 2024, October 2024 and November 2024, but the October 2024 and November 2024 entries did not state the day of the month the swipe test was performed or who performed the swipe test. 5. The first report for the wipe test showed that the wipe test was not performed or recorded for the months of January 2024, March 2024, April 2024 , June 2024, August 2024, September 2024 and December of 2024 6. The second report was completed, but no investigation was made into the incomplete entries that were on the first report. 7. The first report indicated that the May and July 2024 activities were performed on May 31, 2024 and July 29, 2024, and the review dates documented on the second report were conducted before the activity dates recorded on the first report and were dated May 30, 2024 and July 26, 2024 on the second report. -- 3 of 3 --